Microcirculation Assessment in Diabetes and Metabolic Syndrome (MADAME)
Primary Purpose
Coronary Microvascular Dysfunction, Metabolic Syndrome, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Coronary microcirculation assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Microvascular Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Patients with stable angina or inducible myocardial ischemia
- Coronary arteries without high-grade epicardial stenoses (angiographic stenosis < 50% and fractional flow reserve [FFR] > 0.75)
Exclusion Criteria:
- Significant renal insufficiency (serum creatinine > 1.5 mg/dL), a recent (< 1 week) acute coronary syndrome, heart failure, severe valvular disease, or hypertrophic cardiomyopathy.
Sites / Locations
- Interventional Cardiology Unit, Misericordia Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Control, Diabetes and Metabolic Syndrome
Arm Description
Outcomes
Primary Outcome Measures
Coronary Flow Reserve and Index of Microvascular Resistance values
Secondary Outcome Measures
Full Information
NCT ID
NCT01014949
First Posted
November 16, 2009
Last Updated
July 21, 2010
Sponsor
S.M. Misericordia Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01014949
Brief Title
Microcirculation Assessment in Diabetes and Metabolic Syndrome
Acronym
MADAME
Official Title
Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
S.M. Misericordia Hospital
4. Oversight
5. Study Description
Brief Summary
Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. The aim of this study is to invasively assess coronary microcirculation and to investigate the relationship of insulin resistance with coronary microvascular dysfunction.
A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a 5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR) will be calculated as the distal coronary pressure at maximal hyperemia divided by the inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA) index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood examinations before the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microvascular Dysfunction, Metabolic Syndrome, Diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control, Diabetes and Metabolic Syndrome
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Coronary microcirculation assessment
Intervention Description
Patients will arrive to the cardiac catheterization laboratory in a fasting state without discontinuation of their cardiac medications. After conventional diagnostic coronary angiography, 3000-5000 I.U. i.v. heparin will be administered, and a 6F coronary guiding catheter will be placed in the ostium of the coronary artery of interest. A 0.014" coronary pressure wire (Radi Medical Systems, Wilmington, Mass) will be calibrated, equalized to the guiding catheter pressure with the sensor positioned in the coronary ostium, and then advanced to the distal coronary artery (down to at least two thirds of the epicardial vessel length). Coronary flow reserve (CFR), fractional flow reserve (FFR) and the index of microvascular resistance (IMR) will be measured after an intravenous infusion of adenosine [140 ug/kg/min] to induce steady state maximal hyperemia.
Primary Outcome Measure Information:
Title
Coronary Flow Reserve and Index of Microvascular Resistance values
Time Frame
Outcome measures will be assessed at the end of the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stable angina or inducible myocardial ischemia
Coronary arteries without high-grade epicardial stenoses (angiographic stenosis < 50% and fractional flow reserve [FFR] > 0.75)
Exclusion Criteria:
Significant renal insufficiency (serum creatinine > 1.5 mg/dL), a recent (< 1 week) acute coronary syndrome, heart failure, severe valvular disease, or hypertrophic cardiomyopathy.
Facility Information:
Facility Name
Interventional Cardiology Unit, Misericordia Hospital
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21984541
Citation
Picchi A, Limbruno U, Focardi M, Cortese B, Micheli A, Boschi L, Severi S, De Caterina R. Increased basal coronary blood flow as a cause of reduced coronary flow reserve in diabetic patients. Am J Physiol Heart Circ Physiol. 2011 Dec;301(6):H2279-84. doi: 10.1152/ajpheart.00615.2011. Epub 2011 Oct 7.
Results Reference
derived
Learn more about this trial
Microcirculation Assessment in Diabetes and Metabolic Syndrome
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